Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of March
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Forxiga
approved in Europe for type-1 diabetes
25
March 2019 07:00 GMT
Forxiga approved in Europe for type-1
diabetes
Forxiga is the first oral medicine approved in Europe
as an adjunct to insulin for adults with type-1 diabetes and
the
first AstraZeneca medicine ever approved for type-1
diabetes
The
European Commission (EC) has approved Forxiga (dapagliflozin) for use in
type-1 diabetes (T1D) as an adjunct to insulin in patients with a
BMI ≥ 27 kg/m2, when insulin alone
does not provide adequate glycaemic control despite optimal insulin
therapy. This is the first approval of Forxiga for the treatment of
patients with T1D.
Elisabeth Björk, Senior Vice President, Head of late
Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals,
said: "Forxiga is the first oral medicine approved in
Europe as an adjunct to insulin for people living with type-1
diabetes whose glucose levels are not adequately controlled with
insulin alone. We look forward to bringing Forxiga to a patient population that has not had any
approved oral medicines available before."
The
approval is based on data from the Phase III DEPICT clinical
programme for Forxiga in T1D. The short-term (24
week) and long-term (52 week) data from DEPICT-1, along with the
short-term data from DEPICT-2, showed that Forxiga 5mg daily, when given as
an oral adjunct to adjustable insulin in patients with
inadequately-controlled T1D, demonstrated significant and
clinically-meaningful reductions from baseline in average blood
glucose levels HbA1c (primary endpoint), weight and total daily
insulin dose (secondary endpoints) at 24 and 52 weeks.1,2,3
The
safety profile of Forxiga in these T1D trials was
consistent with its well-established profile in type-2 diabetes
(T2D), with the exception of a higher number of diabetic
ketoacidosis (DKA) events in Forxiga-treated patients. DKA is a
known complication for adults with T1D that affects those with T1D
more frequently than with T2D. Forxiga is already indicated as a
monotherapy and as part of combination therapy in adults with T2D
to improve glycaemic control, with the additional benefits of
weight loss and blood pressure reduction, as an adjunct to diet and
exercise.
Forxiga is currently under
regulatory review in Japan and the US for use as an adjunct
treatment to insulin in adults with T1D, with a decision expected
in the first and second half of 2019,
respectively.
About type-1 diabetes
T1D is a chronic disease in which the pancreas produces little or
no insulin. Approximately five percent of people living with
diabetes have type-1. The condition is caused by an autoimmune
reaction that destroys the beta cells in the pancreas which make
insulin.4 Different
factors, including genetics and some viruses, may contribute to
type-1 diabetes.5
About the DEPICT clinical programme
The DEPICT (Dapagliflozin Evaluation
in Patients
with Inadequately Controlled Type
1 Diabetes) clinical trial programme consists of two clinical
trials: DEPICT-1 (NCT02268214) and DEPICT-2 (NCT02460978). DEPICT-1
and DEPICT-2 are 24-week, randomised, double-blinded,
parallel-controlled trials designed to assess the effects
of Forxiga 5mg or 10mg on glycaemic control in patients
with T1D inadequately controlled by insulin. All patients were
evaluated at week 24 and after a 28-week extension (52 weeks in
total). Forxiga 10mg has not been approved for the treatment
of T1D.
About Forxiga
Forxiga (dapagliflozin) is a first-in-class, oral once-daily selective
inhibitor of human sodium-glucose co-transporter 2 (SGLT2)
indicated as both monotherapy and as part of combination therapy to
improve glycaemic control, with the additional benefits of weight
loss and blood pressure reduction, as an adjunct to diet and
exercise in adults with T2D. Forxiga has a robust clinical trial programme of
more than 35 completed and ongoing Phase IIb/III trials in over
35,000 patients, as well as more than 1.8 million patient-years'
experience.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and a key growth driver for the
Company. By following the science to understand more clearly the
underlying links between the heart, kidneys and pancreas,
AstraZeneca is investing in a portfolio of medicines to protect
organs and improve outcomes by slowing disease progression,
reducing risks and tackling co-morbidities. Our ambition is to
modify or halt the natural course of CVRM diseases and potentially
regenerate organs and restore function, by continuing to deliver
transformative science that improves treatment practices and
cardiovascular health for millions of patients
worldwide.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please
visit astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Media Relations
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1.
Dandona P, Mathieu C, Phillip M, et al. Efficacy and safety of
dapagliflozin in patients with inadequately controlled type 1
diabetes (DEPICT-1): 24-week results from a randomised controlled
trial. Lancet Diabetes and Endocrinol. 2017:5;846-17
2. Mathieu
C, Dandona, P, Gillard, P, et al. Efficacy and Safety of
Dapagliflozin in Patients With Inadequately Controlled Type 1
Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized
Controlled Trial. Diabetes Care 2018;41:1938-1946
3.
Dandona P, Mathieu C, Phillip M, et al. Efficacy and safety of
dapagliflozin in patients with inadequately controlled type 1
diabetes: The Depict-1 52 week study. Diabetes Care 2018 Dec;
41(12): 2552-2559
4.
"Diabetes Home." Centers for Disease Control and Prevention,
Centers for Disease Control and Prevention, 15 Aug. 2018,
www.cdc.gov/diabetes/basics/type1.html.
5.
Type 1 Diabetes." Mayo Clinic, Mayo Foundation for Medical
Education and Research, 7 Aug. 2017,
www.mayoclinic.org/diseases-conditions/type-1-diabetes/symptoms-causes/syc-20353011.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
25 March
2019
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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